Abilify lawsuits charge Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Company with being negligent in creating a drug that was defectively designed and manufactured. According to the lawsuits, the companies knew about Abilify’s alleged tendency for causing compulsive behaviors, such as binge eating, hypersexual behavior and compulsive spending, and failed to provide adequate instructions and warning of its risks to the public. More than 440 lawsuits over claims Abilify caused compulsive gambling are currently pending in federal court in Florida.
If you took Abilify and suffered from one of the following adverse events, you may be entitled to compensation.
Number of Lawsuits 441 pending in the multidistrict litigation
Plaintiff Injuries Financial loss due to compulsive gambling; emotional damages
Defendants Otsuka Pharmaceutical Co.; Bristol-Myers Squibb Company
Litigation Status Ongoing
MDL Location U.S. District Court, Northern District of Florida
Top Settlement $515 million to settle federal charges
Users of the antipsychotic drug Abilify (aripiprazole) are suing drug companies, claiming insufficient warning of Abilify’s tendency to cause compulsive gambling cost patients thousands of dollars.
Abilify lawsuits generally allege that the drug’s maker, Otsuka Pharmaceutical, and its marketer, Bristol-Myers Squibb, were negligent in creating a drug that was defectively designed and manufactured.
Post-marketing case reports suggest that Abilify users can experience intense urges and the inability to control these urges while taking the drug.
Drug companies have an obligation to inform the public about any harmful side effects of drugs they create and market.
However, prior to May 2016, Abilify’s label did “not entirely reflect the nature of the impulse-control risk” identified by the U.S. Food and Drug Administration, according to a June 2016 FDA safety announcement.
Hundreds of Abilify compulsive gambling lawsuits have been centralized in Florida and consolidated into a multidistrict litigation, or MDL. This can happen when federal lawsuits share similar characteristics.
The first trials in the MDL are set to begin as early as June 2018. The outcome of these trials can influence settlement agreements. To date, no global settlement has been announced.
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Abilify litigation is ongoing, and attorneys continue to accept new Abilify cases.
In October 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated current and future federal Abilify lawsuits into a multidistrict litigation and transferred the MDL to U.S. District Court in the Northern District of Florida.
The goal of an MDL is to streamline court proceedings for many complex federal cases with similar facts and allegations by moving the cases to a single court and appointing one judge to oversee them. The judicial panel chose U.S. District Judge M. Casey Rodgers to preside over the Abilify MDL.
“Plaintiffs in these actions each allege that they experienced compulsive gambling behaviors as a result of taking Abilify,” the panel said in its transfer order.
“All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.”
- The U.S. Judicial Panel on Multidistrict Litigation, in transfer order
At the time, 22 Abilify lawsuits were pending in 12 districts. The number of total lawsuits in the MDL has grown to 452. As of December 2017, just over 440 lawsuits remained pending.
The Abilify MDL, officially designated MDL 2734, in re: Abilify Products Liability Litigation, is in the discovery phase, which is a period in the early stages of litigation in which the parties exchange information before trial.
The judge presiding over the federal Abilify litigation and the parties involved are in the process of choosing one or more representative cases, called bellwether cases, to be the first cases to go to trial.
The results of bellwether trials help the remaining plaintiffs and defendants decide how to proceed. The bellwether trial process may lead to potential Abilify settlements.
The first Abilify bellwether trial is expected to take place in 2018.
You may be eligible for compensation through a lawsuit if you or your loved one used abilify and experienced harmful compulsive behaviors that resulted in financial, mental and physical damages.
You may be more likely to recover money from Abilify’s makers if you have proof of losing a minimum of $10,000 to compulsive gambling or compulsive spending, or proof of excess weight gain from compulsive eating.
Courts may also award punitive damages against drug companies, which are intended to punish them and ensure that neither they nor other organizations engage in similar behavior in the future.
Doctors prescribe Abilify to treat mental disorders such as schizophrenia, bipolar disorder and major depression. They also prescribe the drug for off-label — or unapproved — uses, including anxiety disorders, dementia, eating disorders, insomnia, obsessive-compulsive disorder and post-traumatic stress disorder. None of the off-label uses have undergone clinical trials to show efficacy or safety.
Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd. and Otsuka America Pharmaceutical Inc. are the companies facing lawsuits over Abilify.
The companies are engaged in the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution and selling of Abilify.
Otsuka Pharmaceutical Co. Ltd. discovered Abilify, which is an atypical antipsychotic prescription medicine. Abilify was first sold in the U.S. in 2002. Bristol-Myers Squibb marketed the drug until 2013.
Lawsuits say Bristol-Myers Squibb and Otsuka knew or should have known that Abilify causes and contributes to an increased risk of uncontrollable compulsive behaviors, such as compulsive gambling.
The companies are accused of designing and manufacturing a defective drug as well as failing to warn, advise, educate or otherwise inform Abilify users or prescribers in the U.S. about the risk of compulsive gambling or other compulsive behaviors.
According to lawsuits, the drug’s U.S. label made no mention of pathological gambling or compulsive behaviors for about 14 years. Yet, labeling in Europe and Canada for the same drug warned about the risk of pathological gambling.
In January 2016, the companies added “pathological gambling” to the Postmarketing Experience section of the U.S. label. However, they made no mention of gambling or compulsive behaviors in the patient medication guide, the source of information most likely viewed by doctors and patients.
People who filed lawsuits against Bristol-Myers Squibb and Otsuka said the drug turned them into compulsive gamblers and sex addicts and ruined their lives. Among those who filed lawsuits are:
In April 2016, Joseph Edgar sued Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd. and Otsuka America Pharmaceutical Inc., alleging that he began to gamble compulsively after he began taking Abilify in April 2009. The gambling problems stopped after he stopped taking the drug in April 2014, but he had lost more than $36,000 and faced other mental and physical damages.
A day after Edgar filed suit in Pennsylvania, a woman named Athalean Harper-Mosley filed a similar suit in California. She claims she began taking Abilify in July 2007, incurred gambling losses of more than $65,000 and stopped having impulsivity problems after she stopped taking the drug in May 2014.
Patrick Parks sued Abilify’s makers in November 2016. Parks began taking the drug around May 2013 and “began compulsively gambling shortly thereafter,” his complaint says. He stopped taking Abilify in August 2014 and stopped gambling. But by then he had already lost more than $75,000.
Similarly, Massachusetts resident Rikki Carlson sued Bristol-Myers Squibb, Otsuka Pharmaceutical and Otsuka American Pharmaceutical alleging that after she began taking Abilify in December 2010, she began compulsively gambling, eating and shopping. Those behaviors stopped after she stopped taking the medication in March 2016.
No global settlement has been announced to resolve the hundreds of cases pending under the Abilify MDL.
Chief Judge M. Casey Rodgers, who is overseeing the Abilify MDL proceedings, appointed experienced legal mediator and negotiator Cathy Yanni as the settlement master on Feb. 28, 2017.
Yanni was involved in similar drug and medical device litigation, including transvaginal mesh, the Medtronic Infuse, Avandia heart attacks and Yaz birth control lawsuits.
Rodgers instructed Yanni to meet with plaintiffs and Otsuka Pharmaceuticals to discuss a settlement.
Federal Abilify gambling lawsuits are currently consolidated into a multidistrict litigation as opposed to a class action.
This means individuals who file federal Abilify gambling lawsuits may be eligible for different amounts of compensation. This is unlike class actions, which limit all participants to a single award amount.
Lawyers who handle complex drug litigation tend to not recommend class actions because every member of the class is awarded the same amount of money no matter the seriousness of their injuries.
Abilify’s label in the U.S. lists serious side effects that have been reported with Abilify, but it did not include gambling until January 2016 when it was added only to the Postmarketing Experience section of the label.
Despite warnings and advisories in Europe and Canada for the same drug sold to patients in the U.S., “the labeling for Abilify in the U.S. did not adequately warn about the risk of compulsive gambling and contained no mention that pathological gambling had been reported in patients prescribed Abilify,” according to lawsuits.
Before May 2016, the label did not include warnings for compulsive behaviors other than pathological gambling, and it did not adequately warn patients about the risk of compulsive gambling. Abilify’s makers also neglected to mention gambling in the patient medication guide.
Between 2002 and 2016, the FDA identified 184 case reports in which there was an association between aripiprazole use and impulse-control problems.
Of the compulsive behaviors, pathological gambling was the most common, with 164 cases. The number only includes reports submitted to the FDA; the agency noted that there could be additional cases about which it is not aware.
These compulsive behaviors can affect anyone who is taking the medicine, and, though rare, they may result in harm to the patient and others if not recognized, the FDA said in a May 3, 2016, Drug Safety Communication.
Within seven months of the FDA’s announcement, the number of Abilify gambling lawsuits had grown to more than 40.
From 2005 to 2013, an FDA report showed Abilify accounted for at least 54 reports of compulsive or impulsive behavior problems, including:
of compulsive gambling
of impulsive behavior
of compulsive shopping
As a result of the FDA’s findings, the agency required new warnings in the drug’s label.
The current Abilify label warns that because “patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.”
The label goes on to say that compulsive behaviors may result in harm to the patient and others if not recognized. It advises doctors to “consider dose reduction or stopping the medication if a patient develops such urges.”
In fall 2012, the European Medicines Agency required Abilify’s makers to warn patients and the European medical community that Abilify use carried the risk of pathological gambling.
The European labeling for Abilify also includes separate information on post-marketing reports of gambling side effects.
In an April 2015 letter, the FDA called Abilify promotional material “false or misleading.”
The agency concluded the material was “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.”
In November 2015, Canadian regulators announced “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality” and concluded there is an increased risk of pathological gambling and hypersexuality with Abilify use.
A warning statement was added to the Canadian prescribing information regarding the risk of pathological gambling.
In May 2016, the FDA published a warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of aripiprazole.
The FDA recommended doctors “make patients and caregivers aware of the risk of these uncontrollable urges,” “closely monitor” patients and consider reducing or stopping Abilify in the event compulsive behavior emerges.
In August 2016, warnings regarding compulsive gambling and other compulsive behaviors were added to the Abilify label.
The number of lawsuits blaming Abilify for compulsive gambling continued to surge.
Five women sued Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical in 2014 and 2015, alleging Abilify caused Type 2 diabetes in children and that the companies failed to warn physicians who prescribed the drug for off-label use of that risk. Those suits, however, were dismissed. They were all filed in New York, and the defendants successfully argued that they would be unable to get out-of-state witnesses to testify.
A U.S. judge tossed federal-court claims that Bristol-Myers Squibb and Otsuka Pharmaceutical paid kickbacks to persuade doctors to prescribe Abilify. Two whistleblowers brought the lawsuit in 2011, pointing to promotions to pediatric psychiatrists as evidence of off-label marketing. Judge William Bertelsman said in his ruling that there was a lack of specific evidence to support the kickback claims. He did, however, permit the whistleblowers to pursue claims that Bristol-Myers fired them to retaliate for their off-label accusations.
It is not illegal for doctors to prescribe a medication for an unapproved use, but it is illegal for drug companies to encourage doctors to do it. Bristol-Myers Squibb has paid two, multimillion-dollar settlements to resolve allegations that it did just that.
The U.S. Department of Justice brought a lawsuit against Bristol-Myers Squibb, accusing the company of promoting Abilify for pediatric use and to treat dementia-related psychosis — both off-label uses.
In 2007, the company paid $515 million to settle federal charges of illegal marketing, including marketing Abilify for off-label use.
The government alleged that, from 2002 to 2005, the company marketed Abilify to nursing homes for use for dementia-related psychosis. Abilify is not FDA-approved for treatment of dementia. In fact, the drug’s label contains a black box warning, the FDA’s strongest warning, stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
The government also claimed Bristol-Myers Squibb sent its sales force to promote the drug to child psychiatrists and other pediatric specialists.
Nearly a decade later, Bristol-Myers Squibb settled a different case over the same practices alleged in the 2007 federal suit— this time with state governments.
The states initiated a consumer-protection investigation in 2009 targeting Otsuka Pharmaceutical and Bristol-Myers Squibb. In December 2016, the company agreed to pay a $19.5 million settlement to 42 states and the District of Columbia to resolve claims it engaged in unfair or deceptive trade practices when marketing Abilify.
Under the settlement, the company can’t make “false or misleading claims” about Abilify or misrepresent findings of clinical studies about the drug.
States sharing the Abilify settlement include: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
“These companies endangered and compromised the health and well-being of millions of Americans in order to turn a profit.”
- Then California Attorney General Kamala D. Harris
“Despite receiving a ‘black box’ warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death, the promotion of Abilify to elderly patients was not halted.”
- Nevada Attorney General Adam Paul Laxalt
“With this multistate settlement, consumers will be armed with better information about medication that could endanger their health.”
- Florida Attorney General Pam Bondi
Please seek the advice of a medical professional before making health care decisions.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.
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